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HURRICANE MEDICAL

USA · Bradenton

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 8Class II 1Class III 0

plus 9 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

Class I 4IIa 6Class Is (sterile) 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 3 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: HURRICANE MEDICAL

FDA 510(k) clearances by year

21999 · K990672

12000 · K993361

FDA listed device types

showing 8 of 9

Unit, Filter, Membrane 1Cannula, Ophthalmic 1Lens, Guide, Intraocular 1Marker, Sclera 1Needle, Aspiration And Injection, Disposable 1Tape And Bandage, Adhesive 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Cystotome 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K993361	TUBING EXTENSION SET	2000-01-04
US	K990672	LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET	1999-05-18
US	K990671	DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE	1999-05-10
BR	81365089002	Canulas Oftalmológicas	Class II
BR	81365080009	FILTRO 0.2 MICRON	Class I

HURRICANE MEDICAL

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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